Chronic Pelvic PainNCT06697548
Conservative Care for Pelvic Pain (C2P2) in Women Service Members
A study testing Pain Neuroscience Education, Lumbopelvic and Hip Therapeutic Exercise and Extrapelvic Manual Therapy in people with Chronic Pelvic Pain, run by Baylor University at 2 sites in United States.
Trial summary
This study will test the effectiveness of emerging conservative interventions for treatment of chronic pelvic pain (CPP) that can be performed without intravaginal specialization. Participants with CPP will be randomly assigned to one of three groups. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Chronic Pelvic Pain
- What is being tested?
- Pain Neuroscience Education, Lumbopelvic and Hip Therapeutic Exercise and Extrapelvic Manual Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 2 sitesUnited States
- Study dates
- Jan 2025to Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 1. Pain of at least 3 months duration in the abdominal-lumbopelvic area, defined as below the umbilicus, between the two ilia, and above the pubic symphysis including the vulvar, perineal, and vaginal regions.
Who cannot join
- Sign that pelvic pain may be due to other serious medical issue (recent history of abdominal pelvic surgery, current infection, disrupted tissue integrity, neoplasm, or history of radiation to the pelvic floor tissue or the tissues being measured for stiffness).
- Chronic debilitating medical conditions (e.g., fibromyalgia, lupus, complex regional pain syndrome, multiple sclerosis or other progressive neurologic condition).
- Currently pregnant or pregnancy in the last 6 months.
- Body mass index over 33 (Waco participants only due to limitation of the instrumentation).
- Soldiers in an Advanced Individual Training (AIT) status.
- Previous intervention to address lumbopelvic muscle stiffness or pain such as dry needling, injections, or soft tissue intervention of any kind in the past 6 months.
- Inability to read English at an 8th grade reading level (any participant unable to read the informed consent form, which will be written at an 8th grade level).
- Inability to legally provide informed consent for any other reason.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites
U.S. Army Medical Center of Excellence (MEDCoE)
San Antonio, Texas, 78234
Melissa Hemphill, DPT, 719-238-5101, Melissa_Hemphill1@baylor.edu
Baylor University
Waco, Texas, 76701
Julianne Six, DPT, 512-705-5745, Julianne_six@baylor.edu
About this study
Official title: Conservative Care for Pelvic Pain (C2P2) in Women Service Members: A Multisite, Multigroup Non-inferiority Randomized Clinical Trial With Development of Clinical Decision Tools
This study will test the effectiveness of emerging conservative interventions for treatment of chronic pelvic pain (CPP) that can be performed without intravaginal specialization. Participants with CPP will be randomly assigned to one of three groups. The first group will receive treatment based on what they normally would receive, including medications, education, and exercise (Usual Care Group). The second group will receive contemporary non-vaginal treatment including manual therapy, dry needling, and specific breathing training (Emerging Field-expedient Care Group). The third group will receive intravaginal treatment by a pelvic health specialist (Gold-standard Intravaginal Specialist Care Group). Participants will be asked about their pain and symptoms and have measurements taken of their pelvic and back muscles after 1, 3, 6, and 12 months. In addition to seeing which treatments work best, clinical decision tools (using medical and trauma history along with clinical examination) will be developed to identify women with CPP likely to respond favorably to non-vaginal conservative interventions. This study will help determine the best non-vaginal treatment strategies for women with CPP and help clinicians quickly determine which patients are likely to benefit from treatment by non-pelvic health physical therapists (e.g., in theater), vs. patients who should be referred for pelvic health specialty care.
Read the detailed description
This trial will measure both clinical outcomes (pain, pelvic floor symptoms, work/duty absenteeism) and physiologic outcomes (pelvic floor and lumbopelvic muscle function and pain sensitivity) at 1 week and after 1, 3, 6, and 12 months of three different conservative physical therapy treatments. It is hypothesized that women who receive emerging field-expedient care will report greater improvements than those who receive only usual care, and their outcomes will be no worse than women who receive gold-standard intravaginal specialist care. Additionally, clinical decision tools incorporating characteristics from medical and trauma history, along with clinical examination, will be developed to identify women with CPP likely to respond favorably to emerging field-expedient care vs. requiring gold-standard intravaginal specialist care.
- Conditions
- Chronic Pelvic Pain
- Being tested
- Pain Neuroscience Education, Lumbopelvic and Hip Therapeutic Exercise, Extrapelvic Manual Therapy, Extrapelvic Dry Needling, Deep Paced Diaphragmatic Breathing Training
- Keywords
- Pelvic health, Chronic pelvic pain, Physical therapy, Military, womens health
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pain Neuroscience EducationOther
Participants will watch and discuss a short (5-minute) standardized pain neuroscience education video with their treating provider. The video explains and illustrates how chronic pain is different than acute pain in that it concerns nervous system hypersensitivity more than local tissue damage. Pain neuroscience education principles from the video will then be used to throughout all interventions to coach the participants through graded exposure of activities that may have previously been painful or provoked anxiety.
Lumbopelvic and Hip Therapeutic ExerciseOther
These motor control exercises will focus on proprioception, coordination, and sensorimotor control training and include progressive exercises that focus on transversus abdominis, lumbar multifidus, diaphragmatic, pelvic floor muscles, and deep hip stabilizers. Exercises will progress from more stabilized (e.g., pelvic tilt, cat and cow) to less stabilized and more dynamic and functional (e.g., forward bending, eccentric squat) to mimic the demands of work duty. Exercise will be trained and progressed during the clinical visits and be performed daily at home.
Extrapelvic Manual TherapyOther
Thrust and non-thrust manual therapy will be applied to the lumbar facet, sacroiliac, and hip joints based upon the clinical exam in a semi-standardized manner
Extrapelvic Dry NeedlingOther
Dry needling treatment to muscles of the lumbopelvic and upper thigh regions in a semi-standardized manner based upon a palpatory examination. The palpatory examination will include the erector spinae, lumbar multifidi, gluteus medius/minimus, piriformis, illiacus, and hip adductor muscles.
Deep Paced Diaphragmatic Breathing TrainingOther
The breathing intervention will start with education describing the link between the diaphragm and the pelvic floor to include awareness of any breath holding patterns and finding positions that facilitate expansion of the ribs, abdominals, and pelvic floor muscles with inhalation. Then progressive training will be given to encourage deep breathing at a pace of approximately 6 breaths per minute.
Chronic Pelvic Pain EducationOther
During the first visit, participants will receive and briefly discuss the 2023 standardized patient educational handout created by the International Pelvic Pain Society with their treating provider. The educational handout describes chronic pelvic pain etiology, typical symptoms, examination, and treatments.
Intravaginal and intrarectal pelvic floor physical therapyOther
Superficial vulvar, perineal and intravaginal manual therapy and biofeedback utilizing commonly used techniques in previous research selected based on identified impairments from the pelvic floor examination will be performed.
| Study group | Role | What they receive |
|---|---|---|
| Usual Care | Active comparator | Usual Care Group will receive their current medical management care along with study-specific patient education and progressive home exercise. Receives: Other: Lumbopelvic and Hip Therapeutic Exercise; Other: Chronic Pelvic Pain Education |
| Emerging Field-expedient Care | Experimental | Emerging Field-expedient Care Group will receive a combination of emerging nonvaginal interventions aimed at normalizing sensory, motor, and autonomic nervous system dysfunction including pain neuroscience education, diaphragmatic breathing training, and lumbopelvic manual therapy and dry needing treatment Receives: Other: Pain Neuroscience Education; Other: Lumbopelvic and Hip Therapeutic Exercise; Other: Extrapelvic Manual Therapy; Other: Extrapelvic Dry Needling; Other: Deep Paced Diaphragmatic Breathing Training; Other: Chronic Pelvic Pain Education |
| Gold-standard Intravaginal Specialist Care | Active comparator | Gold-standard Intravaginal Specialist Care Group will receive tailored intravaginal and intrarectal manual therapy and biofeedback intervention by a pelvic-health specialist. Receives: Other: Pain Neuroscience Education; Other: Lumbopelvic and Hip Therapeutic Exercise; Other: Deep Paced Diaphragmatic Breathing Training; Other: Chronic Pelvic Pain Education; Other: Intravaginal and intrarectal pelvic floor physical therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Pelvic Floor Distress Inventory (PFDI-20)
The Pelvic Floor Distress Inventory (PFDI-20) is a 20-item questionnaire that assesses the frequency and severity of pelvic floor symptoms. It consists of 3 subscales: the pelvic floor distress inventory 6 (POPDI-6), the colorectal anal distress inventory 8 (CRADI-8), and the urinary distress inventory 6 (UDI-6). Each question is rated on a scale of 0-4 with 0 representing "no symptoms," and 4 representing "quite a bit." Higher scores represent more bothersome symptoms.
Measured: 1 week and 1, 3, 6, and 12 months
The Genitourinary Pain Index (GUPI)
The Genitourinary Pain Index (GUPI) is 9-item questionnaire that assesses presence, location, frequency, quality and quantity of genitourinary pain in both men and women.
Measured: 1 week and 1, 3, 6, and 12 months
Secondary outcomes (5)
Numeric pain rating scale (NPRS)
Participants will rate their current pain on a scale of 0-10 with zero being no pain at all and 10 being the worst pain imaginable. Subjects will also rate their worst pain within the past week and their pain at its best within the last week, to gain an assessment of variability and intensity of pain.
Measured: 1 week and 1, 3, 6, and 12 months
Pelvic Floor Muscle Tone
On a subset of 150 participants, pelvic floor muscle tone will be estimated from shear wave elastography ultrasound (US).
Measured: 1 week and 1, 3, 6, and 12 months
Superficial Lumbopelvic Muscle Tone
On a subset of 150 participants, resting tone of several lumbopelvic muscles will be measures using a MyotonPRO device.
Measured: 1 week and 1, 3, 6, and 12 months
Pelvic Floor Pain Sensitivity
On a subset of 150 participants, pelvic floor pain sensitivity will be assessed using pain algometry.
Measured: 1 week and 1, 3, 6, and 12 months
Lumbopelvic Muscle Pain Sensitivity
On a subset of 150 participants, Pain sensitivity of the same lumbopelvic muscles and locations assessed using the MyotonPRO will be measured using a digital hand-held pressure algometer.
Measured: 1 week and 1, 3, 6, and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2024
- Study startJan 2025 (estimated)
- Primary completionJun 2028 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Pelvic PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Baylor University
- Sponsor type
- University, hospital or other
- Collaborators
- Congressionally Directed Medical Research Programs
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06697548
- Sponsor's protocol ID
- OR230127
- Other IDs
- HT94252410709
- Status last verified
- Nov 2024
- First submitted
- 18 Nov 2024
- Last updated
- 20 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Depending upon where the findings of this study are published, sharing individual participant data might not be feasible.
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Conservative Care for Pelvic Pain (C2P2) in Women Service Members: A Multisite, Multigroup Non-inferiority Randomized Clinical Trial With Development of Clinical Decision Tools
- ClinicalTrials.gov ID
- NCT06697548
- Acronym / sponsor ID
- OR230127
- Conditions
- Chronic Pelvic Pain
- Keywords
- Pelvic health, Chronic pelvic pain, Physical therapy, Military, womens health
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Baylor UniversityUniversity, hospital or other
- Collaborators
- Congressionally Directed Medical Research Programs
- Study start
- Jan 2025 (estimated)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 20 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will test the effectiveness of emerging conservative interventions for treatment of chronic pelvic pain (CPP) that can be performed without intravaginal specialization. Participants with CPP will be randomly assigned to one of three groups. The first group will receive treatment based on what they normally would receive, including medications, education, and exercise (Usual Care Group). The second group will receive contemporary non-vaginal treatment including manual therapy, dry needling, and specific breathing training (Emerging Field-expedient Care Group). The third group will receive intravaginal treatment by a pelvic health specialist (Gold-standard Intravaginal Specialist Care Group). Participants will be asked about their pain and symptoms and have measurements taken of their pelvic and back muscles after 1, 3, 6, and 12 months. In addition to seeing which treatments work best, clinical decision tools (using medical and trauma history along with clinical examination) will be developed to identify women with CPP likely to respond favorably to non-vaginal conservative interventions. This study will help determine the best non-vaginal treatment strategies for women with CPP and help clinicians quickly determine which patients are likely to benefit from treatment by non-pelvic health physical therapists (e.g., in theater), vs. patients who should be referred for pelvic health specialty care.
Detailed description
This trial will measure both clinical outcomes (pain, pelvic floor symptoms, work/duty absenteeism) and physiologic outcomes (pelvic floor and lumbopelvic muscle function and pain sensitivity) at 1 week and after 1, 3, 6, and 12 months of three different conservative physical therapy treatments. It is hypothesized that women who receive emerging field-expedient care will report greater improvements than those who receive only usual care, and their outcomes will be no worse than women who receive gold-standard intravaginal specialist care. Additionally, clinical decision tools incorporating characteristics from medical and trauma history, along with clinical examination, will be developed to identify women with CPP likely to respond favorably to emerging field-expedient care vs. requiring gold-standard intravaginal specialist care.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Usual Care | Active comparator | Other: Lumbopelvic and Hip Therapeutic Exercise, Other: Chronic Pelvic Pain EducationUsual Care Group will receive their current medical management care along with study-specific patient education and progressive home exercise. |
| Emerging Field-expedient Care | Experimental | Other: Pain Neuroscience Education, Other: Lumbopelvic and Hip Therapeutic Exercise, Other: Extrapelvic Manual Therapy, Other: Extrapelvic Dry Needling, Other: Deep Paced Diaphragmatic Breathing Training, Other: Chronic Pelvic Pain EducationEmerging Field-expedient Care Group will receive a combination of emerging nonvaginal interventions aimed at normalizing sensory, motor, and autonomic nervous system dysfunction including pain neuroscience education, diaphragmatic breathing training, and lumbopelvic manual therapy and dry needing treatment |
| Gold-standard Intravaginal Specialist Care | Active comparator | Other: Pain Neuroscience Education, Other: Lumbopelvic and Hip Therapeutic Exercise, Other: Deep Paced Diaphragmatic Breathing Training, Other: Chronic Pelvic Pain Education, Other: Intravaginal and intrarectal pelvic floor physical therapyGold-standard Intravaginal Specialist Care Group will receive tailored intravaginal and intrarectal manual therapy and biofeedback intervention by a pelvic-health specialist. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 1. Pain of at least 3 months duration in the abdominal-lumbopelvic area, defined as below the umbilicus, between the two ilia, and above the pubic symphysis including the vulvar, perineal, and vaginal regions.
Key exclusion criteria (8 listed)
- Sign that pelvic pain may be due to other serious medical issue (recent history of abdominal pelvic surgery, current infection, disrupted tissue integrity, neoplasm, or history of radiation to the pelvic floor tissue or the tissues being measured for stiffness).
- Chronic debilitating medical conditions (e.g., fibromyalgia, lupus, complex regional pain syndrome, multiple sclerosis or other progressive neurologic condition).
- Currently pregnant or pregnancy in the last 6 months.
- Body mass index over 33 (Waco participants only due to limitation of the instrumentation).
- Soldiers in an Advanced Individual Training (AIT) status.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pain Neuroscience EducationParticipants will watch and discuss a short (5-minute) standardized pain neuroscience education video with their treating provider. The video explains and illustrates how chronic pain is different than acute pain in that it concerns nervous system hypersensitivity more than local tissue damage. Pain neuroscience education principles from the video will then be used to throughout all interventions to coach the participants through graded exposure of activities that may have previously been painful or provoked anxiety. | Other | Emerging Field-expedient Care, Gold-standard Intravaginal Specialist Care |
| Lumbopelvic and Hip Therapeutic ExerciseThese motor control exercises will focus on proprioception, coordination, and sensorimotor control training and include progressive exercises that focus on transversus abdominis, lumbar multifidus, diaphragmatic, pelvic floor muscles, and deep hip stabilizers. Exercises will progress from more stabilized (e.g., pelvic tilt, cat and cow) to less stabilized and more dynamic and functional (e.g., forward bending, eccentric squat) to mimic the demands of work duty. Exercise will be trained and progressed during the clinical visits and be performed daily at home. | Other | Emerging Field-expedient Care, Gold-standard Intravaginal Specialist Care, Usual Care |
| Extrapelvic Manual TherapyThrust and non-thrust manual therapy will be applied to the lumbar facet, sacroiliac, and hip joints based upon the clinical exam in a semi-standardized manner | Other | Emerging Field-expedient Care |
| Extrapelvic Dry NeedlingDry needling treatment to muscles of the lumbopelvic and upper thigh regions in a semi-standardized manner based upon a palpatory examination. The palpatory examination will include the erector spinae, lumbar multifidi, gluteus medius/minimus, piriformis, illiacus, and hip adductor muscles. | Other | Emerging Field-expedient Care |
| Deep Paced Diaphragmatic Breathing TrainingThe breathing intervention will start with education describing the link between the diaphragm and the pelvic floor to include awareness of any breath holding patterns and finding positions that facilitate expansion of the ribs, abdominals, and pelvic floor muscles with inhalation. Then progressive training will be given to encourage deep breathing at a pace of approximately 6 breaths per minute. | Other | Emerging Field-expedient Care, Gold-standard Intravaginal Specialist Care |
| Chronic Pelvic Pain EducationDuring the first visit, participants will receive and briefly discuss the 2023 standardized patient educational handout created by the International Pelvic Pain Society with their treating provider. The educational handout describes chronic pelvic pain etiology, typical symptoms, examination, and treatments. | Other | Emerging Field-expedient Care, Gold-standard Intravaginal Specialist Care, Usual Care |
| Intravaginal and intrarectal pelvic floor physical therapySuperficial vulvar, perineal and intravaginal manual therapy and biofeedback utilizing commonly used techniques in previous research selected based on identified impairments from the pelvic floor examination will be performed. | Other | Gold-standard Intravaginal Specialist Care |
Primary outcome
The Pelvic Floor Distress Inventory (PFDI-20)
Time frame: 1 week and 1, 3, 6, and 12 months
The Pelvic Floor Distress Inventory (PFDI-20) is a 20-item questionnaire that assesses the frequency and severity of pelvic floor symptoms. It consists of 3 subscales: the pelvic floor distress inventory 6 (POPDI-6), the colorectal anal distress inventory 8 (CRADI-8), and the urinary distress inventory 6 (UDI-6). Each question is rated on a scale of 0-4 with 0 representing "no symptoms," and 4 representing "quite a bit." Higher scores represent more bothersome symptoms.
The Genitourinary Pain Index (GUPI)
Time frame: 1 week and 1, 3, 6, and 12 months
The Genitourinary Pain Index (GUPI) is 9-item questionnaire that assesses presence, location, frequency, quality and quantity of genitourinary pain in both men and women.
5 secondary outcomes
Numeric pain rating scale (NPRS)
Time frame: 1 week and 1, 3, 6, and 12 months
Pelvic Floor Muscle Tone
Time frame: 1 week and 1, 3, 6, and 12 months
Superficial Lumbopelvic Muscle Tone
Time frame: 1 week and 1, 3, 6, and 12 months
Pelvic Floor Pain Sensitivity
Time frame: 1 week and 1, 3, 6, and 12 months
Lumbopelvic Muscle Pain Sensitivity
Time frame: 1 week and 1, 3, 6, and 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2024.
- Individual participant dataSharing planned: No. Depending upon where the findings of this study are published, sharing individual participant data might not be feasible.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pain Neuroscience Education, Lumbopelvic and Hip Therapeutic Exercise and Extrapelvic Manual Therapy in people with Chronic Pelvic Pain, run by Baylor University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 20 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shane Koppenhaver, PhD (210-722-3671, shane_koppenhaver@baylor.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Pelvic Floor Distress Inventory (PFDI-20) (time frame: 1 week and 1, 3, 6, and 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2024.